KDK · Container, Transport, Kidney
Gastroenterology, Urology · 21 CFR 876.5880 · Class 2
Overview
| Product Code | KDK |
|---|---|
| Device Name | Container, Transport, Kidney |
| Regulation | 21 CFR 876.5880 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K053169 | RM3 RENAL PRESERVATION SYSTEM | Waters Instruments, Inc. | Jan 17, 2006 | SESE |
| K911577 | HYPOTRANS MODEL 750 | Martin Mclane Medical | Jul 8, 1992 | SESE |
| K801899 | KEITHLEY LYMPHOCYTE DEPLETION CART | Keithley Development Co. | Sep 26, 1980 | SESE |
Top Applicants
- Keithley Development Co. — 1 clearance
- Martin Mclane Medical — 1 clearance
- Waters Instruments, Inc. — 1 clearance
